Back to results

Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)

Primary Purpose

Gastric Cancer

Status

Recruiting

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Oxaliplatin

Capecitabine

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring Stomach Neoplasms, Chemotherapy, Adjuvant, Oxaliplatin, Capecitabine

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection)
Pathologically confirmed stage II, III patients (AJCC 8th edition)
Age 19 years and older
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
Adequate marrow function (ANC > 1,500/uL, Platelet >100,000/uL, Hb > 8.0 g/dL, patients with chronic anemia who require intermittent blood transfusions can also participate in the study)
Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN).
Adequate hepatic function with serum total bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN
Written, informed consent to the study

Exclusion Criteria:

Female patients who are pregnant or breast-feeding
Positive pregnancy test at baseline (postmenopausal women should be amenorrhea for at least 12 months to be considered non-fertile)
Sexually active men and women who are not willing to implement contraception during study and until 3 months after discontinuation of study drug
Evidence of metastasis (including cytologically confirmed malignant ascites)
Prior systemic chemotherapy or radiation therapy for stomach cancer
Patients who have not recovered from serious complications of gastrectomy
History of other malignancies within the last 3 years (excluding adequately treated basal cell carcinoma of the skin, in situ cancer of the cervix, non-metastatic thyroid cancer)
A history of clinically significant uncontrolled seizures, central nervous system disorders, or mental disorders, which make it impossible to understand the informed consent or interfere with compliance with oral drug intake
Clinically significant (i.e., active) heart disease: e.g. unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure with NYHA grade II or higher, severe cardiac arrhythmias or acute coronary syndrome in the past 6 months (including myocardial infarction)
Lack of integrity or malabsorption syndrome in the upper gastrointestinal tract, which is likely to affect the absorption of study drug
Serious uncontrolled infection or other serious uncontrolled disease
History of allograft requiring immunosuppression therapy
Received any investigational drug or procedure within 4 weeks prior to randomization
Active viral infection (for hepatitis B carrier, patients can be registered if HBV-DNA titer is less than 20,000 IU/mL, and are allowed to use prophylactic antiviral agents by investigator's choice)
Active HIV infection
Patients with peripheral sensory neuropathy with functional impairment

Sites / Locations

Hallym University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control arm

Study arm

Arm Description

Standard adjuvant XELOX 8 cycles Oxaliplatin: 130 mg/m2/day(day 1) Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, total 8 cycles

Adjuvant XELOX 4 cycles followed by capecitabine monotherapy 4 cycles Oxaliplatin: 130 mg/m2/day(day 1) Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, 4 cycles followed by Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, 4 cycles

Outcomes

Primary Outcome Measures

disease-free survival

The disease-free survival (DFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause

Secondary Outcome Measures

overall survival

The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method

Toxicity profiles

Adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 5.0

Full Information

NCT ID

NCT04787354

First Posted

March 2, 2021

Last Updated

February 4, 2022

Sponsor

Hallym University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT04787354

Brief Title

Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)

Official Title

A Randomized Phase 3 Clinical Trial Investigating Optimal Duration of Oxaliplatin Administration in Postoperative XELOX (Oxaliplatin + Capecitabine) Adjuvant Chemotherapy for the Patients With Stage II/III Gastric Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hallym University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study aims to compare the efficacy and safety of reduced adjuvant XELOX treatment (4 cycles of XELOX followed by 4 cycles of capecitabine alone) to standard adjuvant XELOX treatment (8 cycles of XELOX).

Detailed Description

XELOX (oxaliplatin + capecitabine) combination chemotherapy is considered a standard adjuvant treatment for curatively resected gastric cancer patients after it proved its effecacy in the CLASSIC trial. Adjuvant XELOX chemotherapy is a long-term treatment with a total treatment period of 6 months and it is known that about 33% of patients cannot complete treatment schedule due to side effects. In particular, peripheral neuropathy, which is caused by the cumulative administration of oxaliplatin, is a major cause of lowering the patient's quality of life and treatment compliance, and it is known that the incidence rate increases when standard XELOX treatment is continued for more than 6 cycles. In colorectal cancer, clinical studies have been actively conducted to shorten the duration of standard adjuvant chemotherapy to reduce the peripheral sensory neuropathy caused by oxaliplatin, but there are no relevant studies in gastric cancer. This study aims to compare the efficacy and safety of reduced adjuvant XELOX treatment (4 cycles of XELOX followed by 4 cycles of capecitabine alone) to standard adjuvant XELOX treatment (8 cycles of XELOX).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

Stomach Neoplasms, Chemotherapy, Adjuvant, Oxaliplatin, Capecitabine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

976 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control arm

Arm Type

Active Comparator

Arm Description

Standard adjuvant XELOX 8 cycles Oxaliplatin: 130 mg/m2/day(day 1) Capecitabine: 2,000 mg/m2/day(day 1-14), q 3weeks, total 8 cycles

Arm Title

Study arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

Oxaliplatin: 130 mg/m2/day

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

Capecitabine: 2,000 mg/m2/day

Primary Outcome Measure Information:

Title

disease-free survival

Description

The disease-free survival (DFS) will be measured from the start of study treatment until documented tumor progression (by RECIST) or death due to any cause

Time Frame

3-year

Secondary Outcome Measure Information:

Title

overall survival

Description

The overall survival (OS) will be estimated from the start of study treatment until participant's death and measured using the Kaplan-Meier method

Time Frame

5-year

Title

Toxicity profiles

Description

Adverse events will be graded using the NCI common terminology criteria for adverse events (NCTCAE) v 5.0

Time Frame

3-year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma patients who underwent curative surgery (D1 beta or D2 resection) Pathologically confirmed stage II, III patients (AJCC 8th edition) Age 19 years and older Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2 Adequate marrow function (ANC > 1,500/uL, Platelet >100,000/uL, Hb > 8.0 g/dL, patients with chronic anemia who require intermittent blood transfusions can also participate in the study) Adequate renal function, with serum creatinine < 1.5 x upper limit of normal (ULN). Adequate hepatic function with serum total bilirubin ≤ 1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN Written, informed consent to the study Exclusion Criteria: Female patients who are pregnant or breast-feeding Positive pregnancy test at baseline (postmenopausal women should be amenorrhea for at least 12 months to be considered non-fertile) Sexually active men and women who are not willing to implement contraception during study and until 3 months after discontinuation of study drug Evidence of metastasis (including cytologically confirmed malignant ascites) Prior systemic chemotherapy or radiation therapy for stomach cancer Patients who have not recovered from serious complications of gastrectomy History of other malignancies within the last 3 years (excluding adequately treated basal cell carcinoma of the skin, in situ cancer of the cervix, non-metastatic thyroid cancer) A history of clinically significant uncontrolled seizures, central nervous system disorders, or mental disorders, which make it impossible to understand the informed consent or interfere with compliance with oral drug intake Clinically significant (i.e., active) heart disease: e.g. unstable angina requiring medication, symptomatic coronary artery disease, congestive heart failure with NYHA grade II or higher, severe cardiac arrhythmias or acute coronary syndrome in the past 6 months (including myocardial infarction) Lack of integrity or malabsorption syndrome in the upper gastrointestinal tract, which is likely to affect the absorption of study drug Serious uncontrolled infection or other serious uncontrolled disease History of allograft requiring immunosuppression therapy Received any investigational drug or procedure within 4 weeks prior to randomization Active viral infection (for hepatitis B carrier, patients can be registered if HBV-DNA titer is less than 20,000 IU/mL, and are allowed to use prophylactic antiviral agents by investigator's choice) Active HIV infection Patients with peripheral sensory neuropathy with functional impairment

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bum Jun Kim, Dr

Phone

82-31-380-3704

getwisdom1025@gmail.com

Facility Information:

Facility Name

Hallym University Medical Center

City

Gyeonggi-do

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bum Jun Kim

Phone

82-31-380-3704

getwisdom1025@gmail.com

12. IPD Sharing Statement

Learn more about this trial

Optimal Duration of Oxaliplatin in Adjuvant XELOX for Gastric Cancer Patients (EXODOX)

We'll reach out to this number within 24 hrs